Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease - Full Text View

Sponsor:	Kyowa Hakko Kirin Company, Limited
Information provided by:	Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:	NCT00955318

Purpose

The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.

Condition	Intervention	Phase
Parkinson's Disease	Drug: KW-6500	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:

The incidence of adverse events after administration of KW-6500 [ Designated as safety issue: Yes ]
Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in Unified Parkinson's Disease Rating Scale (UPDRS) part III, response ratio, and UPDRS part II score [ Designated as safety issue: No ]

Study Start Date:	July 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
KW-6500: Experimental	Drug: KW-6500 Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have given written informed consent
Patients who have Parkinson's disease
Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
Patients who have experienced a 30% or more improvement in UPDRS partⅢ score when tested for responsiveness to levodopa during the baseline period
Patients who have at least one OFF state per day
Patients who can understand the expression of OFF state, ON state, and dyskinesia
Patients or their families have a desire for self-injection of KW-6500

Exclusion Criteria:

Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
Patients with orthostatic hypotension
Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
Patients with a history of malignant syndrome
Patients with a diagnosis of cancer or evidence of continued disease
Patients who do not test negative in the direct Coombs' test
Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception
Patients who have received MAO inhibitors except selegiline
Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)
Patients with a Mini-Mental State Examination (MMSE) score of 23 or less
Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)
Patients who are receiving methyldopa or 5-HT3 receptor antagonists
Patients who are receiving reserpine or papaverine
Patients who have had a neurosurgical operation for Parkinson's disease
Patients who have had transcranial magnetic stimulation
Patients with a history of drug or alcohol abuse or dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955318

Contacts

Contact: Clinical Science Department

clinical.info@kyowa-kirin.co.jp

Locations

Japan
	Recruiting
Tokyo, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Company, Limited

More Information

No publications provided

Study ID Numbers:	6500-003
Study First Received:	August 7, 2009
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00955318 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010